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Quadrivalent Subunit Influenza Vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: Feb 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07421037Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and OlderPHASE1 ACTIVE NOT_RECRUITING 80 — — Nov 13, 2025Dec 13, 2026Feb 19, 20261 China
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
Within 30 minutes post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination
Within 0-7 days post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination
Within 0-28 days post-vaccination
The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.
On Day 3 post-vaccination
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.
Within 12 months post-vaccination.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Low-dose experimental vaccineEXPERIMENTAL -
High-dose experimental vaccineEXPERIMENTAL -
AdjuvantOTHER -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Quadrivalent Subunit Influenza Vaccine (Adjuvant)BIOLOGICALA single 0.25 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
MF59BIOLOGICALA single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0
0.9% sodium chloride injection (normal saline)BIOLOGICALA single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age at enrollment is ≥65 years (including the 65th birthday). * The participant voluntarily agrees to take part in the trial and has signed the informed consent form. * The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no pl...

Countries:China
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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